Processes for the Preparation of Multicomponent Crystalline Forms of Active Pharmaceutical Ingredients Using Solvent Vapour
AssigneeApotex Inc.
InventorsAlexander J. Stirk, Fabio E. S. Souza, Avedis Karadeolian, Allan W. Rey, Fatemeh Mohammadpourmir
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Abstract
The present invention provides solvent-limited processes for the preparation of an existing crystalline solid form of an active pharmaceutical ingredient comprising mixing, in the presence of solvent vapour, of a solid active pharmaceutical ingredient and a pharmaceutically acceptable entity that is either a high-boiling liquid or a solid. Also provided is the use of a standard rotary apparatus, such as a rotary cone dryer, for application of the processes herein.
Claims64
A process for the preparation of an existing crystalline solid form comprising an active pharmaceutical ingredient and a distinct pharmaceutically acceptable entity, the process comprising mixing, in the presence of solvent vapour, of:
- (i) the active pharmaceutical ingredient in solid form;
- and
- (ii) the pharmaceutically acceptable entity, in solid or liquid form,
- wherein the entity has a melting point greater than approximately 30° C. or a boiling point greater than approximately 150° C. and the pharmaceutically acceptable entity and active pharmaceutical ingredient are incorporated in the same crystalline lattice.
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Dependencies are inferred from the claim text.